Bipolar DepressionPhase 3NCT03249376
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
A Phase 3 study testing Lumateperone in people with Bipolar Depression, run by Intra-Cellular Therapies, Inc. at 47 sites in 6 countries.
Trial summary
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Lumateperone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 47 sitesin 6 countries
- Study dates
- 27 Nov 2017to 1 Mar 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Major Inclusion Criteria:
- male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
- experiencing a current major depressive episode
- able to provide written informed consent
Major Exclusion Criteria:
- any female subject who is pregnant or breast-feeding
- any subject judged to be medically inappropriate for study participation
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
United States14 sites
Clinical Site
Atlanta, Georgia, 30322
Clinical Site
Birmingham, Alabama, 35294
Clinical Site
Bothell, Washington, 98011
Clinical Site
Buffalo, New York, 14215
Clinical Site
Charlotte, North Carolina, 28211
Clinical Site
Chicago, Illinois, 60612
Clinical Site
Decatur, Georgia, 30030
Clinical Site
Joliet, Illinois, 60435
Clinical Site
Miami, Florida, 33133
Clinical Site
Orange City, Florida, 32763
Clinical Site
Sherman Oaks, California, 91403
Clinical Site
Shreveport, Louisiana, 71101
Clinical Site
St Louis, Missouri, 63128
Clinical Site
The Woodlands, Texas, 77381
Bulgaria10 sites
Clinical Site
Burgas
Clinical Site
Kardzhali
Clinical Site
Lovech
Clinical Site
Plovdiv
Clinical Site
Rousse
Clinical Site
Sofia
Clinical Site
Targovishte
Clinical Site
Tsarev Brod
Clinical Site
Varna
Clinical Site
Veliko Tarnovo
Ukraine9 sites
Clinical Site
Ivano-Frankivsk
Clinical Site
Kharkiv
Clinical Site
Kherson
Clinical Site
Lviv
Clinical Site
Odesa
Clinical Site
Poltava
Clinical Site
Smila
Clinical Site
Uzhhorod
Clinical Site
Vinnytsia
Russia8 sites
Clinical Site
Moscow
Clinical Site
Nizhny Novgorod
Clinical Site
Omsk
Clinical Site
Saint Petersburg
Clinical Site
Samara
Clinical Site
Saratov
Clinical Site
Tomsk
Clinical Site
Yekaterinburg
Colombia3 sites
Clinical Site
Barranquilla
Clinical Site
Bello
Clinical Site
Pereira
Serbia3 sites
Clinical Site
Belgrade
Clinical Site
Kragujevac
Clinical Site
Novi Sad
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
- Conditions
- Bipolar Depression
- Being tested
- Lumateperone, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumateperoneDrug
Also called ITI-007
Lumateperone 42 mg (ITI-007 60 mg tosylate)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone | Experimental | Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks Receives: Drug: Lumateperone |
| Placebo | Placebo comparator | Placebo administered once daily every evening for 6 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Measured: Baseline to Day 43
Secondary outcomes (2)
Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score
The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score.
Measured: Baseline to Day 43
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good.
Measured: Baseline to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start27 Nov 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Kozauer, MD, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249376
- Sponsor's protocol ID
- ITI-007-404
- Status last verified
- May 2022
- First submitted
- 11 Aug 2017
- Last updated
- 3 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Durgam S, Lakkis H, Kozauer SG, Chen C, McIntyre RS. Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials. CNS Spectr. 2025 Sep 29;30(1):e80. doi: 10.1017/S1092852925100564.
PubMed 41017591McIntyre RS, Durgam S, Huo J, Kozauer SG, Stahl SM. The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features. J Clin Psychiatry. 2023 Apr 24;84(3):22m14739. doi: 10.4088/JCP.22m14739.
PubMed 37103915Calabrese JR, Durgam S, Satlin A, Vanover KE, Davis RE, Chen R, Kozauer SG, Mates S, Sachs GS. Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Am J Psychiatry. 2021 Dec;178(12):1098-1106. doi: 10.1176/appi.ajp.2021.20091339. Epub 2021 Sep 23.
PubMed 34551584
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally
- ClinicalTrials.gov ID
- NCT03249376
- Acronym / sponsor ID
- ITI-007-404
- Conditions
- Bipolar Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Posted 3 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumateperone | Experimental | Drug: LumateperoneLumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered once daily every evening for 6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumateperoneAlso: ITI-007Lumateperone 42 mg (ITI-007 60 mg tosylate) | Drug | Lumateperone |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to Day 43
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
2 secondary outcomes
Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score
Time frame: Baseline to Day 43
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score
Time frame: Baseline to Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41017591Durgam S, Lakkis H, Kozauer SG, Chen C, McIntyre RS. Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials. CNS Spectr. 2025 Sep 29;30(1):e80. doi: 10.1017/S1092852925100564.
- Derived from this study: PubMed 37103915McIntyre RS, Durgam S, Huo J, Kozauer SG, Stahl SM. The Efficacy of Lumateperone in Patients With Bipolar Depression With Mixed Features. J Clin Psychiatry. 2023 Apr 24;84(3):22m14739. doi: 10.4088/JCP.22m14739.
- Derived from this study: PubMed 34551584Calabrese JR, Durgam S, Satlin A, Vanover KE, Davis RE, Chen R, Kozauer SG, Mates S, Sachs GS. Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Am J Psychiatry. 2021 Dec;178(12):1098-1106. doi: 10.1176/appi.ajp.2021.20091339. Epub 2021 Sep 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Kozauer, MD study director
Intra-Cellular Therapies, Inc.
47 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumateperone in people with Bipolar Depression, run by Intra-Cellular Therapies, Inc. at 47 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Bulgaria, Ukraine, Russia, Colombia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline to Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03249376, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.